The Randomized Controlled Trial of Finerenone Therapy for Pediatric Hennoch Scholein Nephritis With Mild Proteinuria
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
研究概览
简要总结
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. About 40% of HSPN cases are accompanied by mild proteinuria, and some of them progress to end-stage renal disease. Currently, the treatment for children with mild proteinuria HSPN mainly involves ACEI/ARB, but long-term use of these drugs can lead to an increase in aldosterone levels, affecting therapeutic efficacy. Finerenone can improve vascular endothelial cell dysfunction and renal tissue inflammation and fibrosis, and reduce urinary protein in patients with glomerular diseases. This study intends to conduct an exploratory randomized controlled clinical trial of finerenone in children with HSPN accompanied by a small amount of proteinuria to evaluate the efficacy and safety of finerenone treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of HSPN meet the following conditions① Age > 3 years old and < 18 years old;
- •24-hour urine protein quantification >= 8mg/h/M2 body surface area (or >= 300mg/d), and < 20mg/h/M2 body surface area (< 1000mg/d);
- •Sign the informed consent form.
排除标准
- •Abnormal renal function: eGFR < 90 ml/min/1.73m^2 body surface area;
- •Renal pathological grade >= IV;
- •Application of glucocorticoids and/or immunosuppressants within 2 weeks;
- •Recent applications involving high-dose glucocorticoids administered for a duration exceeding two weeks.;
- •Liver transaminase > 2 times the upper limit of normal;
- •Severe cardiac insufficiency;
- •Simultaneous use of CYPA4 inhibitors;-
研究组 & 干预措施
Finerenone group
干预措施: ACEI / ARB+finerenone (Drug)
Control group
干预措施: ACEI/ARB (Drug)
结局指标
主要结局
Percentage of Subjects with a Reduction in 24-Hour Urinary Protein Excretion ≥30% from Baseline
时间窗: 3 months
次要结局
未报告次要终点